Updated with additional information and new stock price.
will not be required to conduct new clinical trials of its prostate cancer treatment Provenge in order to seek European approval late this year or early in 2012, the company said Friday.
If all goes as planned, Dendreon expects European regulator to approve Provenge to in the first half of 2013. Provenge is a personalized vaccine unique to each prostate cancer patient. To sell the treatment in Europe, Dendreon plans first to hire a contract manufacturer to make Provenge while the company concurrently builds its own European manufacturing facility to be located in Germany.
Dendreon did not disclose the cost of building that European manufacturing plant, nor how long construction will take. The company did say that it will need to raise additional funds to complete its European expansion.
Provenge sales in 2010 totaled $48 million, the company said, slightly ahead of Wall Street's consensus estimate of $47 million.Dendreon forecast 2011 Provenge sales of $350 million to $400 million, in line with current consensus of $370 million.
Provenge is currently manufactured for U.S. patients at a company-owned facility in New Jersey expected to reach full capacity later this quarter, pending FDA approval. Two additional U.S. Provenge plants are under construction, expected to be completed and operational in the middle of the year.
Dendreon shares were up 2% to $36.17 in recent trading.
--Written by Adam Feuerstein in Boston.
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